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临床试验/NCT04897932
NCT04897932Unknown不适用

An Evaluation of the Usability and Efficacy of a Prototype Handheld Urinal for Adults Who Suffer From Nocturia, Urge, Frequency, and/or Functional Incontinence

Binding Sciences Limited2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年5月30日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
Changes in fluid intake

研究概览

简要总结

Usability and efficacy evaluation of a prototype handheld urinal for adult use

详细描述

28 day usability and efficacy evaluation by 154 adults in domestic settings who suffer one or more of nocturia, urge, frequency or functional incontinence.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Suffers from nocturia urge, frequency, or funnctional incontinence

排除标准

  • Suffers only from stress UI

结局指标

主要结局

Changes in fluid intake

时间窗: 28 days

Quantitative analysis of levels of daily fluid intake i) when using the device and ii) not using the device.

Levels of user confidence

时间窗: 28 days

Qualitative self-assessments, on a three-point scale of "Not at all confident", "Reasonably confident" and "Very confident", by users of their confidence in their ability to manage urinary incontinence when using the device in a range of different orientations. Tool: questionairre

Change in level of user independence

时间窗: 28 days

Quantitative assessment of number of carer interventions required to assist users with urinary toileting when using and not using the device. Tool: user diary and questionairre

Change in incidence of falls associated with urinary toileting

时间窗: 28 days (3 months reported number of falls based on participant's recollection of incidence during that period)

Quantitative analysis of the number of falls incurred going to and from toilet while using the device over the 28 day study period compared to the number of falls recalled by participants going to and from the toilet during the 3 months prior to the study when not using the device. Tool: user diary and questionairre

Convenience in use

时间窗: 28 days

Qualitative self-assessment by users of the convenience in use of the device relative to other continence aids used on a three-point scale: "More convenient", "Neither more nor less convenient", and "Less convenient". Tool: questionairre

次要结局

未报告次要终点

研究者

发起方
Binding Sciences Limited
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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